HTX-011 in Spinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2022-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 2B Upper Extremity Nerve Block Study

NCT03011333

Postoperative Pain

COMPLETED PHASE2

A Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy

NCT02504580

Postoperative Pain

COMPLETED PHASE2

Pediatric Postoperative Analgesia Herniorrhaphy Study

NCT03922048

Analgesia

WITHDRAWN PHASE2

A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE

NCT06109428

Analgesia

COMPLETED PHASE4

Extended Delivery of Bupivacaine Study in Herniorrhaphy

NCT04102267

Analgesia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Operative Pain Lumbar Laminectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Optional Part B will be randomized, blinded, active-controlled.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: Bupivacaine HCl

Bupivacaine HCl without epinephrine, via injection into the surgical site.

Group Type EXPERIMENTAL

Bupivacaine HCI without epinephrine

Intervention Type DRUG

100 mg administered via injection into the surgical site.

Cohort 2: HTX-011

HTX-011 (bupivacaine/meloxicam) via application into the surgical site.

Group Type EXPERIMENTAL

HTX-011

Intervention Type DRUG

HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.

Luer Lock Applicator

Intervention Type DEVICE

Applicator for instillation.

Cohort 3: HTX-011

HTX-011 (bupivacaine/meloxicam) via application into the surgical site.

Group Type EXPERIMENTAL

HTX-011

Intervention Type DRUG

HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.

Luer Lock Applicator

Intervention Type DEVICE

Applicator for instillation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine HCI without epinephrine

100 mg administered via injection into the surgical site.

Intervention Type DRUG

HTX-011

HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.

Intervention Type DRUG

Luer Lock Applicator

Applicator for instillation.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Is scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia.
* Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.

Exclusion Criteria

* Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
* Has functioning intrathecal drug pump or spinal cord stimulator.
* Opioid use for most days within the last 3 months.
* Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled surgery.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
* Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation.
* Has impaired balance and is at risk of falling.
* Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
* Has undergone 3 or more surgeries within 12 months.
* Has a known history of glucose-6-phosphate dehydrogenase deficiency.
* Has History of liver cirrhosis, having an aspartate aminotransferase \>3 × the upper limit of normal (ULN), or having an alanine aminotransferase \>3 × ULN.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No